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CN108156808A - Conduit and balloon catheter - Google Patents

Conduit and balloon catheter Download PDF

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Publication number
CN108156808A
CN108156808A CN201680002385.2A CN201680002385A CN108156808A CN 108156808 A CN108156808 A CN 108156808A CN 201680002385 A CN201680002385 A CN 201680002385A CN 108156808 A CN108156808 A CN 108156808A
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CN
China
Prior art keywords
layer
mentioned
outer layer
protrusion
internal layer
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN201680002385.2A
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Chinese (zh)
Other versions
CN108156808B (en
Inventor
久保佑太
荻堂盛贵
桂田武治
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Asahi Intecc Co Ltd
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Asahi Intecc Co Ltd
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Publication of CN108156808A publication Critical patent/CN108156808A/en
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Publication of CN108156808B publication Critical patent/CN108156808B/en
Active legal-status Critical Current
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/005Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0009Making of catheters or other medical or surgical tubes
    • A61M25/0012Making of catheters or other medical or surgical tubes with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/0045Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M2025/006Catheters; Hollow probes characterised by structural features having a special surface topography or special surface properties, e.g. roughened or knurled surface
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0183Rapid exchange or monorail catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1079Balloon catheters with special features or adapted for special applications having radio-opaque markers in the region of the balloon
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1088Balloon catheters with special features or adapted for special applications having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/005Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A61M25/0052Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0108Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/104Balloon catheters used for angioplasty

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

The subject of the invention is to provide a kind of in the case that even if in outer layer, (preceding extreme direction and rear extreme direction) is stretched in an axial direction, outer layer is not easy to the conduit and balloon catheter removed from internal layer.In conduit (1), outer layer (40) has protrusion (50) in the position of the recess portion (24) of internal layer (10), the protrusion (50) penetrates through gap (25) and deeper enters than enhancement layer (coil case) (30), and extend in the axial direction, so as to improve the bond strength of internal layer (10) and outer layer (40), and, the anchoring effect of layer (coil case) (30) hooking firmly is reinforced according to the protrusion (50) of outer layer (40), conduit (1) is being inserted into blood vessel, bile duct, durings ductus pancreaticus etc., in the case that even if in outer layer (40), in narrow part or choking portion, (preceding extreme direction and rear extreme direction) is stretched in an axial direction, also the possibility that outer layer (40) is removed from internal layer (10) can be reduced.

Description

Conduit and balloon catheter
Technical field
The present invention relates in order to which to being formed in blood vessel, either choking portion is diagnosed or controlled the narrow part in digestive organs The conduit and balloon catheter treated and used.
Background technology
If it is formed with narrow part or choking portion, blood, bile (bile), pancreatic juice etc. in blood vessel, bile duct, ductus pancreaticus etc. Flowing is deteriorated.As to this narrow part method that either choking portion is diagnosed or treated, carry out used conduit extensively Diagnosis or therapy.
Usually, conduit have the internal layer of tubulose, the outer layer coated to the periphery of internal layer and be configured at internal layer with Enhancement layer between outer layer.Conduit makes internal layer be engaged with outer layer via enhancement layer, therefore is all difficult to improve internal layer anyway With the bond strength of outer layer.
As this method is solved the problems, such as, there is known such as downcomers:By being set in internal layer from the gap of enhancement layer Outer layers side is prominent and axially extending and bite the protruding portion of outer layer, so as to improve the bond strength of internal layer and outer layer (for example, With reference to following patent documents 1).
However, in the conduit recorded in patent document 1, the protruding portion of internal layer is only from one direction of rear end forward end Extension.Accordingly, there exist following problems:Outer layer by narrow part or choking portion extreme direction has stretched forward when, outer layer easily from Internal layer is removed.In addition, the protruding portion of internal layer is only provided at than enhancement layer in the outer part.Therefore, bending is being inserted a catheter into In the case of blood vessel, bile duct, ductus pancreaticus etc., due to guiding-tube bend, stress concentration is in the protruding portion of internal layer and the joint portion of outer layer, Still remain the problem of outer layer is easily removed from internal layer.
Existing technical literature
Patent document
Patent document 1:No. 2015/012185 pamphlet of International Publication No.
Invention content
Problems to be solved by the invention
The present invention is in view of this thing and the scheme that proposes, even if subject is to provide one kind in outer layer in axial direction (front end Direction and rear extreme direction) on be stretched in the case of, outer layer is not easy to the conduit and balloon catheter removed from internal layer.
Solution for solving the problem
The above subject is solved by following solved scheme.
The solution of the present invention 1 is a kind of conduit, which is characterized in that is had:The internal layer of tubulose;In above-mentioned internal layer or on The periphery of internal layer is stated, the enhancement layer of above-mentioned wire rod is wound in a manner of there is gap between adjacent wire rod;And to above-mentioned The outer layer that enhancement layer is coated, above-mentioned internal layer have the peripheral surface of concaveconvex shape, and the peripheral surface of the concaveconvex shape is in above-mentioned line The position of material, which is formed with protrusion, is formed with recess portion in the position in above-mentioned gap forms, and above-mentioned outer layer is in the above-mentioned recessed of above-mentioned internal layer The position in portion has protrusion, which penetrates through above-mentioned gap and deeper enter than above-mentioned enhancement layer, and in the axial direction Extension.
Conduit of the solution of the present invention 2 according to scheme 1, which is characterized in that the axis of the above-mentioned protrusion of above-mentioned outer layer To length it is longer than the axial length in the above-mentioned gap of above-mentioned enhancement layer.
The solution of the present invention 3 is a kind of balloon catheter, is had:Conduit described in scheme 1 or 2;And it is engaged in above-mentioned outer The air bag of layer, above-mentioned balloon catheter are characterized in that above-mentioned outer layer has recessed in a manner of the above-mentioned peripheral surface along above-mentioned internal layer The peripheral surface of convex form, the peripheral surface of the concaveconvex shape are formed with protrusion in the position of above-mentioned wire rod, in the position in above-mentioned gap It is formed with recess portion to form, above-mentioned air bag enters the above-mentioned recess portion of above-mentioned outer layer.
The effect of invention
In the conduit of the solution of the present invention 1, internal layer has the peripheral surface of concaveconvex shape, and the peripheral surface of the concaveconvex shape exists The position of wire rod is formed with protrusion, the position in gap between adjacent wire rod is formed with recess portion and forms, and outer layer is in the recessed of internal layer The position in portion has protrusion, which penetrates through gap and deeper enter than enhancement layer, and extend in the axial direction.Cause This, improves the bond strength of internal layer and outer layer, moreover, being reinforced the anchoring effect of layer hooking firmly according to the protrusion of outer layer, i.e., Make in the case that (preceding extreme direction and rear extreme direction) is stretched in an axial direction, can also be dropped by narrow part or choking portion in outer layer The possibility that low outer layer is removed from internal layer.
In the conduit of the solution of the present invention 2, the axial length of the protrusion of outer layer is than the axial direction in the gap of enhancement layer Length it is longer.Therefore, the anchoring effect of the protrusion of outer layer and enhancement layer not only becomes larger, but also also become radially axially Greatly, as a result, more enough further possibilities for reducing outer layer and being removed from internal layer.
In the balloon catheter of the solution of the present invention 3, outer layer has concaveconvex shape in a manner of the peripheral surface along internal layer Peripheral surface, the peripheral surface of the concaveconvex shape, which is formed with protrusion in the position of wire rod, is formed with recess portion in the position in gap forms, and And air bag enters the recess portion of outer layer.Due to improving the bond strength of air bag and outer layer, even if air bag is made to expand radially In the case of, the possibility that air bag is removed from outer layer can be also reduced.In addition, by the way that air bag is made to enter the recess portion of outer layer, from And can assure the bond strength of air bag and outer layer, and the thickness of air bag can be made thinning, as a result, it is possible to improve air bag to lead Pipe relative to blood vessel, bile duct, ductus pancreaticus etc. insertion.
Description of the drawings
Fig. 1 is the whole overall diagram for the conduit for representing first embodiment.
Fig. 2 is the enlarged drawing in the A portions for being exaggerated Fig. 1.
Fig. 3 is the sectional view for the B-B sections for representing Fig. 2.
Fig. 4 be the conduit of second embodiment with the comparable sectional views of Fig. 3.
Fig. 5 be the conduit of third embodiment with the comparable sectional views of Fig. 3.
Fig. 6 be the conduit of the 4th embodiment with the comparable enlarged drawings of Fig. 2.
Fig. 7 is the sectional view for the C-C sections for representing Fig. 6.
Fig. 8 be the conduit of the 5th embodiment with the comparable sectional views of Fig. 3.
Fig. 9 is the whole overall diagram for the balloon catheter for representing sixth embodiment.
Figure 10 is the enlarged drawing in the D portions for being exaggerated Fig. 9.
Figure 11 be the balloon catheter of the 7th embodiment with the comparable sectional views of Figure 10.
Figure 12 be the conduit of the 8th embodiment with the comparable sectional views of Fig. 3.
Figure 13 be the conduit of the 9th embodiment with the comparable sectional views of Fig. 3.
Specific embodiment
The conduit 1 of first embodiment is illustrated with reference to Fig. 1~Fig. 3.In fig. 1 it is illustrated that left side becomes to internal Front end side (far side), the right side of insertion become the rear end side (proximal side) operated by operators such as doctors.Fig. 2 is to be exaggerated figure The enlarged drawing in 1 A portions, Fig. 3 are the sectional views for the B-B sections for representing Fig. 2.
Conduit 1 is, for example, in order to the narrow part conduit that either choking portion is diagnosed or treated and used.Such as Fig. 1 institutes Show, conduit 1 mainly has catheter shaft 60, the sheet material 70 for the front end for being engaged in catheter shaft 60 and after being engaged in catheter shaft 60 The conjugation tube 80 at end.
As shown in Fig. 2, catheter shaft 60 has successively since inside in the radial direction:Internal layer 10;In the internal layer 10 with The mode with gap 25 is wound with the enhancement layer (coil case) 30 of wire rod 20 between adjacent wire rod 20;And to enhancement layer The outer layer 40 that (coil case) 30 is coated.In addition, it in fig. 2, in order to help to understand, represents to have removed a part for outer layer 40 State.
Internal layer 10 is formed by resin, and can be inserted into seal wire or other conduits in inside.The resin material for forming internal layer 10 does not have It is particularly limited to, but in the first embodiment, uses PTFE (polytetrafluoroethylene (PTFE)).
In internal layer 10, equipped with the coil case 30 as enhancement layer.Towards front end side right direction wound skein product 20 and shape Into the coil case 30.As the material for the wire rod 20 for forming coil case 30, in the first embodiment, stainless steel has been used (SUS304), but it's not limited to that.Such as the metal materials such as tungsten, Ni-Ti alloys are not used only, it can also use and strengthen modeling Expect resin materials such as (PEEK).In addition, the coiling direction for forming the wire rod 20 of coil case 30 can also be left towards front end side Direction.
In the periphery of coil case 30, the outer layer 40 being made of resin is formed with, internal layer 10 and coil case 30 are wrapped It covers.The resin material for forming outer layer 40 is not particularly limited, and uses polyamide, polyamide elastomer, polyester, polyurethane etc..
The sheet material 70 being made of resin is bonded in the front end of above-mentioned catheter shaft 60 (with reference to Fig. 1).Form the sheet material 70 Resin be not particularly limited, but be made of polyurethane, polyurethane elastomer etc..Alternatively, it is also possible to make sheet material 70 containing radiation The powder of line impermeability.For example, radioactive ray impermeability is contained by range of the sheet material 70 in about 65w%~about 90w% Powder (for example, tungsten powder), so as to which when carrying out coronarography, the operators such as doctor can accurately hold conduit 1 Position.
As shown in figure 3, internal layer 10 has the peripheral surface 15 of concaveconvex shape, the peripheral surface 15 of the concaveconvex shape is in wire rod 20 Position, which is formed with protrusion 22, is formed with recess portion 24 in the position in gap 25 forms.In addition, recess portion 24 of the outer layer 40 in internal layer 10 Position has protrusion 50, which penetrates through gap 25 and deeper enter than enhancement layer (coil case) 30, and in axis It upwardly extends.
The protrusion 50 of outer layer 40 becomes close to trapezoidal shape.Compared to wire rod 20 immediate vicinity (in other words, adjacent Protrusion 22 between immediate place) upper bottom length L1, the length L2 longer of the bottom near the recess portion 24 of internal layer 10 (L2 > L1).In addition, the peripheral surface 15 of outer layer 40 along the concaveconvex shape of internal layer 10 has the inner peripheral surface 42 of corresponding concaveconvex shape.
In conduit 1, outer layer 40 has protrusion 50, the protrusion 50 perforation gap in the position of the recess portion 24 of internal layer 10 25 and deeper enter than enhancement layer (coil case) 30, and extend in the axial direction, so as to improve connecing for internal layer 10 and outer layer 40 Intensity is closed, and the anchoring effect of 30 hooking of layer (coil case) firmly is reinforced by the protrusion 50 of outer layer 40, is inserted by conduit 1 Whens entering to blood vessel, bile duct, ductus pancreaticus etc., even if in outer layer 40 in narrow part or choking portion (preceding extreme direction and rear end in an axial direction Direction) be stretched in the case of, can also reduce the possibility that outer layer 40 is removed from internal layer 10.
Then, the conduit 2 of second embodiment is illustrated with reference to Fig. 4.If only pair with conduit 1 shown in Fig. 3 not It is illustrated with putting, then in conduit 2, the inner peripheral surface of the coil case 30 as enhancement layer is buried in internal layer 10a, the opposing party Face, the peripheral surface of the coil case 30 as enhancement layer are buried in outer layer 40a.Internal layer 10a has the peripheral surface of concaveconvex shape 15a, the peripheral surface 15a of the concaveconvex shape are formed with protrusion 22a in the position of wire rod 20, are formed with recess portion in the position in gap 25 24a is formed.In addition, outer layer 40a has protrusion 50a, protrusion 50a perforations gap in the position of the recess portion 24a of internal layer 10a 25 and deeper enter than enhancement layer (coil case) 30, and extend in the axial direction.
Identical with the protrusion 50 of conduit 1, the protrusion 50a of outer layer 40a becomes close to trapezoidal shape.Compared to wire rod 20 Immediate vicinity (in other words, the immediate place between adjacent protrusion 22a) upper bottom length L3, in the recessed of internal layer 10a The length L4 longer (L4 > L3) of bottom near portion 24a.In addition, peripheral surfaces of the outer layer 40a along the concaveconvex shape of internal layer 10a 15a has the inner peripheral surface 42a of corresponding concaveconvex shape.
Identical with conduit 1 in conduit 2, outer layer 40a has protrusion 50a in the position of the recess portion 24a of internal layer 10a, should Protrusion 50a penetrates through gap 25 and deeper enters than enhancement layer (coil case) 30, and extend in the axial direction, in improving The bond strength of layer 10a and outer layer 40a, and it is reinforced what 30 hooking of layer (coil case) was lived according to the protrusion 50a of outer layer 40a Anchoring effect, when conduit 2 is inserted into blood vessel, bile duct, ductus pancreaticus etc., even if in outer layer 40a on narrow part or choking portion edge In the case that axial (preceding extreme direction and rear extreme direction) is stretched, the possibility that outer layer 40a is removed from internal layer 10a can be also reduced Property.
Then, the conduit 3 of third embodiment is illustrated with reference to Fig. 5.If only pair with conduit 1 shown in Fig. 3 not It is illustrated with putting, then in conduit 3, the coil case 30 as enhancement layer is formed in the periphery of internal layer 10b.Internal layer 10b has The peripheral surface 15b of concaveconvex shape, the peripheral surface 15b of the concaveconvex shape are formed with protrusion 22b in the position of wire rod 20, in gap 25 Position be formed with recess portion 24b and form.In addition, outer layer 40b has protrusion 50b in the position of the recess portion 24b of internal layer 10b, it should Protrusion 50b penetrates through gap 25 and deeper enters than enhancement layer (coil case) 30, and extend in the axial direction.
Identical with the protrusion 50 of conduit 1, the protrusion 50b of outer layer 40b becomes close to trapezoidal shape.Compared to adjacent Protrusion 22b between immediate place upper bottom length L5, the length L6 of the bottom near the recess portion 24b of internal layer 10b compared with Long (L6 > L5).In addition, the peripheral surface 15b of outer layer 40b along the concaveconvex shape of internal layer 10b forms the inner circumferential of corresponding concaveconvex shape Face 42b.
Identical with conduit 1 in conduit 3, outer layer 40b has protrusion 50b in the position of the recess portion 24b of internal layer 10b, should Protrusion 50b penetrates through gap 25 and deeper enters than enhancement layer (coil case) 30, and extend in the axial direction, in improving The bond strength of layer 10b and outer layer 40b, and it is reinforced what 30 hooking of layer (coil case) was lived according to the protrusion 50b of outer layer 40b Anchoring effect, when conduit 3 is inserted into blood vessel, bile duct, ductus pancreaticus etc., even if in outer layer 40b on narrow part or choking portion edge In the case that axial (preceding extreme direction and rear extreme direction) is stretched, the possibility that outer layer 40b is removed from internal layer 10b can be also reduced Property.
Then, the conduit 4 of the 4th embodiment is illustrated with reference to Fig. 6 and Fig. 7.If only pair with Fig. 2 and Fig. 3 institutes The difference of conduit 1 shown illustrates, then in conduit 4, has successively since inside in the radial direction:Internal layer 10c; Multiple wire rod 20a, 20b are mutually woven into internal layer 10c and there is the enhancement layer of gap 25a between adjacent wire rod 20a, 20b (braiding layer) 35;And the outer layer 40c coated to enhancement layer (braiding layer) 35 (with reference to Fig. 6).In addition, in figure 6, in order to Help understands, represents to have removed the state of a part of outer layer 40c.
Enhancement layer (braiding layer) 35 be the first wire rod 20a and the second wire rod 20b mutually with mesh-shape (sieve-mesh) be woven into and Into layer, the first wire rod 20a towards front end side right direction wind, on the other hand, the second wire rod 20b towards front end side to the left To winding.In the 4th embodiment, alternately it is woven into 8 first wire rod 20a and 8 second wire rod 20b and amounts to 16 (8 × 8 Root) wire rod, so as to form enhancement layer (braiding layer) 35.
The material of the first wire rod 20a and the second wire rod 20b of enhancement layer (braiding layer) 35 are formed either identical material Material, can also use different materials.In the 4th embodiment, the first wire rod for being made of tungsten has been used and by stainless steel (SUS304) the second wire rod formed, but be not particularly limited, the resin material other than metal can also be used (for example, strengthening Plastics).
As shown in fig. 7, internal layer 10c has the peripheral surface 15c of concaveconvex shape, the peripheral surface 15c of the concaveconvex shape is first The position of wire rod 20a and the second wire rod 20b, which is formed with protrusion 22c, is formed with recess portion 24c in the position of gap 25a forms.Separately Outside, there is outer layer 40c protrusion 50c, protrusion 50c to penetrate through gap 25a and compare and add in the position of the recess portion 24c of internal layer 10c Strong layer (braiding layer) 35 deeper enters, and extend in the axial direction.
The protrusion 50c of outer layer 40c becomes close to trapezoidal shape.Compared to the First Line for forming enhancement layer (braiding layer) 35 The length at the upper bottom of the immediate vicinity of material 20a and the second wire rod 20b (in other words, immediate place between adjacent protrusion 22c) L7, the length L8 longer (L8 > L7) of the bottom near the recess portion 24c of internal layer 10c.In addition, outer layer 40c is along the recessed of internal layer 10c The peripheral surface 15c of convex form has the inner peripheral surface 42c of corresponding concaveconvex shape.
In conduit 4, outer layer 40c in the position of the recess portion 24c of internal layer 10c there is protrusion 50c, protrusion 50c to pass through Lead to gap 25 and deeper enter than enhancement layer (braiding layer) 35, and extend in the axial direction, so as to improve internal layer 10c and outer layer The bond strength of 40c, moreover, the anchoring effect of 35 hooking of layer (braiding layer) firmly is reinforced according to the protrusion 50c of outer layer 40c, When conduit 4 is inserted into blood vessel, bile duct, ductus pancreaticus etc., even if in outer layer 40c in narrow part or choking portion (front end in an axial direction Direction and rear extreme direction) be stretched in the case of, can also reduce the possibility that outer layer 40c is removed from internal layer 10c.
Then, the conduit 5 of the 5th embodiment is illustrated with reference to Fig. 8.If only pair with conduit 1 shown in Fig. 3 not It is illustrated with point, then in conduit 5, internal layer 10d has the peripheral surface 15d, the peripheral surface 15d of the concaveconvex shape of concaveconvex shape Protrusion 22d is formed in the position of wire rod 20, recess portion 24d is formed in the position in gap 25 and forms.In addition, including outer layer 40d Layer 10d recess portion 24d position have protrusion 50d, the protrusion 50d perforation gap 25 and than enhancement layer (coil case) 30 more Enter deeply, and extend in the axial direction.
Identical with the protrusion 50 of conduit 1, the protrusion 50d of outer layer 40d becomes close to trapezoidal shape.Compared to wire rod 20 Immediate vicinity (in other words, the immediate place between adjacent protrusion 22d) upper bottom length L9, in the recessed of internal layer 10d Length (in other words, the axial maximum length of the protrusion 50d of outer layer 40d) L10 longer (L10 > of bottom near portion 24d L9).In addition, length (in other words, the axial maximum of the protrusion 50d of outer layer 40d of the bottom of the protrusion 50d of outer layer 40d Length) L10 than the gap 25 of enhancement layer (coil case) 30 axial length L11 long (L10 > L11) (reference Fig. 8).Also, The peripheral surface 15d of outer layer 40d along the concaveconvex shape of internal layer 10d has the inner peripheral surface 42d of corresponding concaveconvex shape.
In this way, in conduit 5, length (in other words, the protrusion of outer layer 40d of the bottom of the protrusion 50d of outer layer 40d The axial maximum length of 50d) L5 than the gap 25 of enhancement layer (coil case) 30 axial length L6 long, even if so as to outside In the case that layer 40d is stretched to radial outside, the protrusion 50d of outer layer 40d is also reinforced 30 hooking of layer (coil case) and lives, energy Outer layer 40d is enough reduced from internal layer 10d to the possibility of radial direction stripping.The protrusion 50d of outer layer 40d and enhancement layer (coil as a result, Body) 30 anchoring effect not only becomes larger, but also also become larger radially in the axial direction.
Then, the balloon catheter 6 of sixth embodiment is illustrated with reference to Fig. 9 and Figure 10.Figure 10 is to be exaggerated Fig. 9 D portions enlarged drawing.Balloon catheter 6 is, for example, to be used to be expanded and treated to narrow part or choking portion using treatment Balloon catheter.
As shown in figure 9, balloon catheter 6 mainly by air bag 90, sheet material 100, outer shaft 110, inner shaft 60a, intensive aspect 120, with And conjugation tube 130 is formed.
The air bag 90 expanded to narrow part or choking portion is made of resin parts, and the front end of air bag 90 is engaged in The front end of inner shaft 60a and sheet material 100, the rear end of air bag 90 are engaged in the front end of outer shaft 110.
Outer shaft 110 is to form to supply the liquid such as contrast agent, normal saline solution to expand air bag 90 The tubular part of expanding lumen 116.Outer shaft 110 since front end side successively include front end outside axle portion 111, guidewire port portion 113, Axle portion 117 outside intermediate outer axle portion 115 and rear end.Axle portion 111 and intermediate outer axle portion 115 are by polyamide, polyamide outside front end The pipe that the resins such as elastomer, polyolefin, polyester, polyester elastomer are formed.Guidewire port portion 113 is the axle portion outside front end that is interconnected 111st, the part of intermediate outer axle portion 115 and inner shaft 60a.
Axle portion 111 is inserted into inner shaft 60a outside front end, is formed with above-mentioned expansion between axle portion 111 and inner shaft 60a outside front end Open tube chamber 116.
Axle portion 117 is the metal tubular part of referred to as so-called hypotube outside rear end.The front end of axle portion 117 is inserted outside rear end Enter and be engaged in the rear end of axle portion 115 outside centre.The rear end of axle portion 117 is equipped with conjugation tube 130 outside rear end.If from that can pacify The supply (not shown) of pressurizer loaded on conjugation tube 130 is for liquid such as contrast agent, the normal saline solutions expanded to air bag 90 Body, then liquid air bag 90 is expanded by expanding lumen 116.In addition, the material of axle portion 117 does not limit especially outside rear end It is fixed, the superelastic alloy such as stainless steel (SUS302, SUS304), Ni-Ti alloys can be used.
Inner shaft 60a forms the guidewire lumen 62 for being internally inserted into seal wire.In addition, the rear end of inner shaft 60a passes through engagement Rear end side guidewire port 134 is formed in the guidewire port portion 113 of outer shaft 110.Operator can be from the rear end side guidewire port 134 replace seal wire.
Sheet material 100 is bonded in the front end of the front end of inner shaft 60a and air bag 90.Sheet material 100 is formed by soft resin. Although material is not particularly limited, polyurethane, polyurethane elastomer etc. can be used.In addition, front end sheet 100 has in front end There is front end side guidewire port 133.
The inner circumferential of the front end of axle portion 117 is equipped with intensive aspect 120 outside rear end.Intensive aspect 120 is that section is round and court The made of metal wire rod of forward end and the cone-shaped of thin footpath.The material of intensive aspect 120 is not particularly limited, and can use stainless steel (SUS304), the superelastic alloy such as Ni-Ti alloys.The intensive aspect 120 by axle portion outside centre 115 and guidewire port portion 113, And extend to axle portion 111 outside front end.In addition, intensive aspect 120 has the promotion part 122 that can be connected to guidewire port portion 113.
In the inside of air bag 90, in the periphery of inner shaft 60a, there are two concentrator markers 95 for installation.The operators such as doctor exist as a result, Can accurately be held during coronarography the position of air bag 90, as a result, reliably to narrow part or choking portion Carrying out expansion becomes easy.
As shown in Figure 10, inner shaft 60a has successively since inside in the radial direction:Internal layer 10e;In internal layer 10e The enhancement layer (coil case) 30 of wire rod 20 is wound between interior adjacent wire rod 20 in a manner of with gap 25;And to enhancement layer The outer layer 40e that (coil case) 30 is coated.
Internal layer 10e has the peripheral surface 15e of concaveconvex shape, and the peripheral surface 15e of the concaveconvex shape is in the position shape of wire rod 20 It is formed into having protrusion 22e, being formed with recess portion 24e in the position in gap 25.In addition, recess portion 24es of the outer layer 40e in internal layer 10e There is protrusion 50e, protrusion 50e to penetrate through gap 25 and deeper enter than enhancement layer (coil case) 30, Er Qie for position Axis upwardly extends.
Identical with the protrusion 50 of conduit 1, the protrusion 50e of outer layer 40e becomes close to trapezoidal shape.Compared to wire rod 20 Immediate vicinity (in other words, the immediate place between adjacent protrusion 22e) upper bottom length L12, in the recessed of internal layer 10e Length (in other words, the axial maximum length of the protrusion 50e of outer layer 40e) L13 longer (L13 > of bottom near portion 24e L12).In addition, the peripheral surface 15e of outer layer 40e along the concaveconvex shape of internal layer 10e has the inner peripheral surface 42e of corresponding concaveconvex shape.
In the position of the recess portion 24e of internal layer 10e there is protrusion 50e, protrusion 50e to pass through in inner shaft 60a, outer layer 40e Lead to gap 25 and deeper enter than enhancement layer (coil case) 30, and extend in the axial direction, so as to improve internal layer 10e and outer layer The bond strength of 40e, and the anchoring effect of 30 hooking of layer (coil case) firmly is reinforced according to the protrusion 50e of outer layer 40e, Whens balloon catheter 6 is inserted into blood vessel, bile duct, ductus pancreaticus etc., even if in outer layer 40e at axial (preceding extreme direction and rear extreme direction) On be stretched in the case of, can also reduce the possibility that outer layer 40e is removed from internal layer 10e.
Also, outer layer 40e has the peripheral surface 45 of concaveconvex shape, and the peripheral surface 45 of the concaveconvex shape is with along internal layer 10e's The mode of peripheral surface 15e is formed with protrusion 46 in the position of wire rod 20, is formed with recess portion 48 in the position in gap 25 and forms.
Air bag 90 enters the recess portion 48 of outer layer 40e and is engaged in the peripheral surface 45 of outer layer 40e.In other words, in air bag 90 Front end, equipped with the protruding portion 92 to be protruded into the inside circumferential direction of the mode of the recess portion 48 of outer layer 40e.
In this way, it is engaged by the protruding portion 92 to air bag 90 and the recess portion 48 of outer layer 40e, so as to improve 90 He of air bag Even if the bond strength of outer layer 40e in the case where air bag 90 is made to expand radially, can also reduce air bag 90 from outer layer The possibility of 40e strippings.In addition, by the way that air bag 90 is made to enter the recess portion 48 of outer layer 40e, so as to assure air bag 90 and outer layer The bond strength of 40e, and the thickness of air bag 90 can be made thinning, as a result, it is possible to improve balloon catheter 6 relative to blood vessel, The insertion of bile duct, ductus pancreaticus etc..
In addition, as Fig. 9 and inner shaft 60a of balloon catheter shown in Fig. 10 6, the first~the 5th can also be used to implement The conduit 1~5 of mode.
In addition, in the inner shaft 60a of balloon catheter 6, since inside there is internal layer 10e successively in the radial direction, strengthen Layer (coil case) 30 and the outer layer 40e coated, but it's not limited to that.For example, as shown in figure 11, implement the 7th In the balloon catheter 7 of mode, inner shaft 60b between internal layer 10e and adjacent wire rod 20 in internal layer 10e with gap 25 mode is wound with the enhancement layer (coil case) 30 of wire rod 20.In other words, different from balloon catheter 6, inner shaft 60b does not have outer layer 40e。
If the difference only pair from balloon catheter 6 shown in Fig. 10 illustrates, in balloon catheter 7, air bag 90a into Enter the recess portion 24e of internal layer 10e and be engaged in the peripheral surface 15e of internal layer 10e.Specifically, recess portions of the air bag 90a in internal layer 10e There is protrusion 50f, protrusion 50f to penetrate through gap 25 and deeper enter than enhancement layer (coil case) 30 for the position of 24e, and And extend in the axial direction.
The protrusion 50f of air bag 90a becomes close to trapezoidal shape.It is (in other words, adjacent compared to the immediate vicinity of wire rod 20 Protrusion 22 between immediate place) upper bottom length L14, the length L15 of the bottom near the recess portion 24e of internal layer 10e Longer (L15 > L14).
In balloon catheter 7, air bag 90a has the position protrusion 50f in the recess portion 24e of internal layer 10e, the protrusion 50f penetrates through gap 25 and deeper enters than enhancement layer (coil case) 30, and extend in the axial direction, so as to improve internal layer 10e With the bond strength of air bag 90a, moreover, according to the protrusion 50f of air bag 90a be reinforced 30 hooking of layer (coil case) live anchoring Effect, when balloon catheter 7 is inserted into blood vessel, bile duct, ductus pancreaticus etc., even if existing in air bag 90a in narrow part or choking portion In the case that axial (preceding extreme direction and rear extreme direction) is stretched, the possibility that air bag 90a is removed from internal layer 10e can be also reduced Property.
In addition, by the way that air bag 90 is made to enter the recess portion 24e of internal layer 10e, so as to assure air bag 90a and internal layer 10e's Bond strength, and the thickness of air bag 90a can be made thinning, as a result, it is possible to improve balloon catheter 7 relative to blood vessel, bile duct, The insertion of ductus pancreaticus etc..
In addition, in above-mentioned conduit 1~5 and balloon catheter 6,7, to outer layer 40,40a, 40b, 40c, 40d, 40e The protrusion 50f of protrusion 50,50a, 50b, 50c, 50d, 50e and air bag 90a is illustrated with approaching trapezoidal shape, But which kind of shape can.
For example, as shown in figure 12, in the conduit 8 of the 8th embodiment, internal layer 10f has the peripheral surface of concaveconvex shape 15f, the peripheral surface 15f of the concaveconvex shape are formed with protrusion 22f in the position of wire rod 20, are formed with recess portion in the position in gap 25 24f is formed.In addition, outer layer 40f has protrusion 50g, protrusion 50g perforations gap in the position of the recess portion 24f of internal layer 10f 25 and deeper enter than enhancement layer (coil case) 30, and extend in the axial direction.
The protrusion 50g of outer layer 40f becomes L-shaped.Compared to wire rod 20 immediate vicinity (in other words, in adjacent protrusion Immediate place between 22f) upper bottom length L16, the length L17 longer of the bottom near the recess portion 24f of internal layer 10f (L17 > L16).In addition, the peripheral surface 15f of outer layer 40f along the concaveconvex shape of internal layer 10f has the inner circumferential of corresponding concaveconvex shape Face 42f.
In addition, in conduit 8, only extreme direction extends the protrusion 50g of outer layer 40f, but it's not limited to that, also may be used backward Be only forward extreme direction extension shape.
In addition, as shown in figure 13, in the conduit 9 of the 9th embodiment, internal layer 10g has the peripheral surface of concaveconvex shape 15g, the peripheral surface 15g of the concaveconvex shape are formed with protrusion 22g in the position of wire rod 20, are formed with recess portion in the position in gap 25 24g is formed.In addition, outer layer 40g has protrusion 50h, protrusion 50h perforations gap in the position of the recess portion 24g of internal layer 10g 25 and deeper enter than enhancement layer (coil case) 30, and extend in the axial direction.
The protrusion 50h of outer layer 40g is divided into two strands near the recess portion 24g of internal layer 10g.Center compared to wire rod 20 is attached The closely length L18 at the upper bottom in (in other words, the immediate place between adjacent protrusion 22g), it is attached in the recess portion 24g of internal layer 10g The length L19 longer (L19 > L18) of near bottom.In addition, outer layer 40g has along the peripheral surface 15g of the concaveconvex shape of internal layer 10g There is the inner peripheral surface 42g of corresponding concaveconvex shape.
Also, in the above description, coil case 30 and braiding layer 35 are instantiated, but and be defined in as enhancement layer This.For example, as conduit 1~5,8,9 and balloon catheter 6,7, can also spiral helicine cut be set in hypotube (metal tube) Seam, and use using the joint-cutting as the enhancement layer in gap.
The explanation of symbol
1~5,8,9-conduit, 6,7-balloon catheter, the peripheral surface of 10~10g-internal layer, 15~15g-internal layer, 20, 20a, 20b-wire rod, 22~22g-protrusion (internal layer), 24~24g-recess portion (internal layer), 30,35-enhancement layer, 40~40g- Outer layer, the inner peripheral surface of 42~42g-outer layer, 46-protrusion (outer layer), and 47-recess portion (outer layer), 50~50h-protrusion, 60- Catheter shaft, 60a, 60b-inner shaft, 70,100-sheet material, 80,130-conjugation tube, 90,90a-air bag, 92-protruding portion, 110-outer shaft, 120-intensive aspect.

Claims (3)

1. a kind of conduit, which is characterized in that have:
The internal layer of tubulose;
In above-mentioned internal layer or the periphery of above-mentioned internal layer, above-mentioned line is wound in a manner of there is gap between adjacent wire rod The enhancement layer of material;And
To the outer layer that above-mentioned enhancement layer is coated,
Above-mentioned internal layer has the peripheral surface of concaveconvex shape, and the peripheral surface of the concaveconvex shape is formed with convex in the position of above-mentioned wire rod Portion is formed with recess portion in the position in above-mentioned gap and forms,
Above-mentioned outer layer has protrusion in the position of the above-mentioned recess portion of above-mentioned internal layer, the protrusion penetrate through above-mentioned gap and than above-mentioned Enhancement layer deeper enters, and extends in the axial direction.
2. conduit according to claim 1, which is characterized in that
The axial length of the above-mentioned protrusion of above-mentioned outer layer is longer than the axial length in the above-mentioned gap of above-mentioned enhancement layer.
3. a kind of balloon catheter, has:
Conduit described in claims 1 or 2;And
The air bag of above-mentioned outer layer is engaged in,
Above-mentioned balloon catheter is characterized in that,
Above-mentioned outer layer has a peripheral surface of concaveconvex shape in a manner of the above-mentioned peripheral surface along above-mentioned internal layer, the concaveconvex shape it is outer Circumferential surface, which is formed with protrusion in the position of above-mentioned wire rod, is formed with recess portion in the position in above-mentioned gap forms,
Above-mentioned air bag enters the above-mentioned recess portion of above-mentioned outer layer.
CN201680002385.2A 2016-09-21 2016-09-21 Catheter and balloon catheter Active CN108156808B (en)

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EP3517161A4 (en) 2020-08-26
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US20180078743A1 (en) 2018-03-22
EP3517161B1 (en) 2021-06-16
WO2018055706A1 (en) 2018-03-29
US10722682B2 (en) 2020-07-28
KR20200036062A (en) 2020-04-06
CN108156808B (en) 2021-04-23
EP3517161A1 (en) 2019-07-31
KR20180044834A (en) 2018-05-03

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